Special Populations

Hepatic Impairment

Acromegaly

Sub-Q

In patients with moderate to severe hepatic impairment, initially, 60 mg once every 4 weeks for 3 months.1 Subsequent dosages are determined based on GH and IGF-1 concentrations and clinical response.1

Renal Impairment

Acromegaly

Sub-Q

In patients with moderate to severe hepatic impairment, initially, 60 mg once every 4 weeks for 3 months.1 Subsequent dosages are determined based on GH and IGF-1 concentrations and clinical response.1

Endocrine Effects

Hypoglycemia or hyperglycemia can occur as a result of inhibition of insulin and glucagon secretion.1 Monitor blood glucose concentrations when lanreotide therapy is initiated or dosage adjusted in patients with diabetes mellitus.110 Adjust dose of antidiabetic agents as necessary.1 (See Interactions.)

Cardiovascular Effects

Specific Populations

Pregnancy

Lactation

Not known whether lanreotide is distributed into milk. 1 Discontinue nursing or the drug. 1

Pediatric Use

Safety and efficacy not established.1

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1

Hepatic Impairment

Clearance may be decreased; dosage adjustment recommended for patients with moderate to severe hepatic impairment.1 (See Hepatic Impairment under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Renal Impairment

Clearance may be decreased; dosage adjustment recommended for patients with moderate to severe renal impairment.1 (See Renal Impairment under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Somatuline Depot Pharmacokinetics

Absorption

Bioavailability

Mean bioavailability was 73.4, 69, and 78.4% following sub-Q administration of single 60-, 90-, and 100-mg dosages, respectively.1 A drug depot is formed at the injection site allowing for sustained release.1

Peak levels obtained during the first day following sub-Q administration.1